June 21, 2016
(Washington, D.C.) — Today’s Senate Judiciary Subcommittee hearing on S. 3056, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, is an important step toward ensuring competition and affordability in the prescription drug marketplace, the Pharmaceutical Care Management Association (PCMA) said.
The bipartisan legislation, introduced by Senators Charles Grassley (R-IA), Patrick Leahy (D-VT), Amy Klobuchar (D-MN), and Mike Lee (R-UT), will encourage more development of generic and biosimilar drugs and reduce overall drug costs by preventing brand drug manufacturer abuses of risk evaluation and mitigation strategies (REMS) that block generic competition.
The CREATES Act addresses this problem in a number of ways, including by allowing parties to bring actions in federal court to obtain drug samples necessary to develop generic versions of brand drugs. It also would authorize judges to award damages to prevent future similar abuses.
“This legislation will help bring generics to market faster, which is key to reducing drug costs,” said PCMA President and CEO Mark Merritt.
The legislation is supported by a broad group of stakeholders, including the Generic Pharmaceutical Association, the Academy of Managed Care Pharmacy, Public Citizen, Consumers Union, and the Blue Cross Blue Shield Association.
Other potential solutions for high drug prices that the Food and Drug Administration and Congress could consider include:
- Accelerating FDA approvals of drugs that face little or no competition;
- Making copay coupons an illegal kickback for all insurance that receives any federal subsidy;
- Modernizing Medicaid pharmacy to make it more like the commercial market and Medicare Part D; and
- Creating new incentives for physicians to prescribe biosimilars.